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Thursday, January 20, 2011

Medtronic to Host PEEK Lab

Spine Nation:

It was reported on the Street that the "Evil Empire" will be holding a lab for spine surgeons this weekend in Memphis on the use of PEEK Rods. Looks like there will be a windfall this weekend for the Pole Dancers at Platinum Plus. PEEK RODS? So the first question that must be asked is, Why PEEK Rods? And if so, are PEEK Screws that far behind? But the bigger question that must be asked is, "will PEEK Rods improve the clinical outcomes? TSB and one of our sources on the Street had an interesting conversation about MDT this afternoon. What happens to a company when it becomes the market leader and no longer offers innovation and is purely marketing driven? Do you launch TSRH 3D at the North American Spine Society Meeting and call it innovation? Do you launch another cervical plate? Do you launch a resorbable plate only to have it cannibalize an already cannibalized portfolio? Has Medtronic become the Apple of the Industry?

Medtronic may be the leader in terms of market share, but with the exception of INFUSE, what has it done lately? Hawkins never liked spine, if not for the margins. If he had his druthers, he probably rather not play in this arena, but that's no longer his concern. At a time that hospitals are capping pricing for lumbar fusions, how will PEEK Rods drive down the price of a procedure? If anything, PEEK will drive up the cost. Getting excited about PEEK Rods is like getting excited about Trans 1's Butt Bolt. You know the product that everyone loves to hype yet questions remain about the efficacy of cleaning the disc space and the end plates so that the surgeon can achieve boney apposition. So TSB wants to know what our bloggers think. Are your surgeons game for Memphis? Do they like Bar-B-Que? Are they Blues aficionado's? Do they like coming home with Stripper perfume? TSB wants to know what y'all think?

125 comments:

PEEK Rods have been available for quite some time. Interesting recent study shows patient perception of a clinical outcome, based on radiographic images, with broken peek rods is much better than a broken TI rod. Just goes to show, "what do patients know?"

What could be better when things are not well in Big Blue Land? An old Memphis junket to remind all those surgeons of days gone by. History is a terrible thing to waste.

Maybe Eddie T will get his game face back on with his Peabody Penthouse routine .......... or maybe ........ Kuzio and his big time routine will make an appearance. Who knows though. Times are tough. And, maybe the Platinum Club has been so decimated by a lack of revenue over the past 6 years due to the DOJ and Advamed that they are dropping prices to a point that no one, not even Grassley, could say no to a girl trying to put herself through school.

Huh...old time junket-I hope a Massachusetts or Vermont Doctor doesn't attend...it would be a shame to fly all that way and not be able to eat on Beale!! Peak rod...wow if thats Medtronics latest innovation- I guess the big blue gorilla ran out of IP in spine. Best of luck for the rest of the metal companies...

PEEK rods are just another "sexy" product on the market. They have been around for a while and DePuy has published some biomechanical studies on them as well. "Theoretically", these rods allow for greater anterior column load sharing, thereby leading to better fusion. Its hard to detect if the rod is broken though. Interesetingly, Paul McAfee presented a study in recent NASS showing that load sharing through PEEK rods were just as good as titanium rods...At the end of the day, I guess its just another sales gimmick by MSD... At least someone (read strippers) would benefit from this.

It's my understanding that Medtronic and Depuy are the only companies with PEEK rods, and the FDA is not approving them for anyone else until they have more data. Sounds like Medtronic is trying to capitalize on the duopoly before it becomes a commodity like everything else they have.

They've had PEEK rods for several years now and tried desperately to force the market with good old Rusty Knuckles. This had nothing to do with market innovation but realizing Solera was about 7 years too late they would have to go down another path. So they looked around and said what do we got? Squat! They had banked on motion and lost. They had banked on Kyphon and lost. They had banked on some dude from Japan and lost. They banked on just being MDT and lost. They kept the same turds in charge and continue to loose. Like Platinum Plus, the lights have come on and the usual suspects are being exposed.

I use MDT b/c they are the best company in the field today. Ethical, fair, responsive, innovative and with the most sincere and knowledgeable reps available. Their products are superior to every other companies and they have a solution for all my needs. If it were not for MDT I would not be as successful as I am today...your honor.

-PEEK Rods have been around for at least 2 years now-Platinum Plus has been closed for 4 years (God rest her soul)-Peek screws? Come on dude.....

Peek rods have an interesting angle, they drastically reduce the stress at the bone screw interface (via load sharing) which is valuable in patients with sub par bone to reduce haloing and toggle, and as mentioned in a prior post augments the "wolfes Law" theory in conjunction with anterior fixation. Its by no means a barnbuster and is not for every patient, it can only be used up to 2 levels for starters. What it does do is add another option for patient specific treatments that not every company has...see Peek Rods, Cobalt Chrome, CHrome +, Ti CP, Ti Alloy, SS, Blasted Ti...and so on.

And speaking of products that do or do not affect outcomes, I actually think that Solera and the Osteogrip thread pattern DO have something to offer. If you can reduce toggle and avoid haloing, then you can also reduce revision surgeries to replace loose or even broken screws due to such forces.

I am not such a kool-aid drinker that I just grandfather all MDT products in as fantastic and clinically superior to the next. Case and point, the resorbable ACDF plate is a joke in my opinion and I would never approach a customer with it. There are SOOO many products in the MDT bag, and newsflash... they are not all home runs! But many of them are, couple that with things like O-Arm, national contracts, massive sales force and market presence and you have a difficult gorilla to compete with.

Just as an FYI for you Medtronic blowhards, TSB has been fully aware of PEEK Rods since the Memry Corporation based in Bethel Connecticut began working with the Evil Empire let's say roughly 7-8 years ago. As for having my face deep in the Bear's crotch, you must be mistaking me for Robin Young. I guess no one would find it absurd that you would hold a workshop on PEEK Rods, let me LOL. Go make some new offset connectors for the 3D and call it innovation.

I am a former Medtronic rep and PEEK rods have been out close to 4 years it seems. I remember the regional compensation plan meeting where they put an incentive on PEEK rods, Agile dynamic stabilization and Prestige cervical disc. Prestige wasn't even FDA cleared yet and there wasn't a single study on Agile or PEEK rods to even suggest that they were as good as, much less better than SS or Ti. We didn't even have to ask why they were putting the focus on these products, the theme of that meeting and the NSM was "Differentiation", no one else had those products. They even went as far as saying that PEEK rods had a low barrier to entry into the market so we needed to act fast because everyone else was going to have one within 2 years. It didn't turn out that way for a few reasons. We all know what happened with Agile, complete fail, and Prestige hasn't done much either.

We did ask why they designed the PEEK rod so that it wouldn't fit into any of our existing screws and their response was that they felt the oval shape improved biomechanics. Yet, they didn't know what biomechanical goal they were shooting for since this type product had never been studied. We all knew the real reason was that it created a new catalog number for the screw that would now be classified as "new technology" and the price was set accordingly.

It was a bit of a defining moment for the company and for me. I have since left and I feel they also have left their once great path. Does anybody remember the term "integrity pricing"? This was their way to charge more because they bore the burden of doing "all" of the R and D in the industry and everyone else just copied them. It was bull then and even more so these days. The only product they announced at NASS was a freaking curette for the Kyphon system. I guess all the R and D money goes to CRM, but not to spine.

They ain't who they used to be, no leaders, too many lawyers, too many consultants and bogus IP deals and a sense of entitlement to the business. Someone above asked why they are still the market leader? It's because they had such a huge lead and they grew that lead for over a decade. But the lead is dwindling, and it will take a while, but they will blow it eventually unless they have a major change of course.

You really do sound like you plagiarized the sales brochure. I would submit to you that a PEEK rod in the dimensions that Medtronic offers has a similar stiffness to a CP Ti or Ti alloy Solera rod. In other words, you could achieve the same purported goals with your shiny new Solera system without having to market and produce PEEK rod systems.

Also, Osteogrip screws do not prevent toggle. They purportedly increase pullout strength, but that has yet to be proven in an independent study. I like the idea, but you would have a hard time convincing me that 1/2 of the thread surface area in the cancellous portion of the screw and similar surface area in the cortical portion increases pullout or reduces toggle. The toggle comes from axial loading and the shape of the screw is largely irrelevant. Your reps are also selling bogus info that a 4.75 CoCr rod is as stiff as a 5.5 SS rod. The 2 metals have similar modulus of elasticity (flexibility), but CoCr feels stronger because its yield strength is greater and that is what the surgeons feel when they bend or cut the rod. Once its in, it is of similar stiffness to SS, in fact some SS alloys are stiffer than CoCr.

In my opinion, both of these are smoke and mirrors. Osteogrip has higher insertional torque than Legacy which gives the impression of better bite, but it is simply due to the steeper thread pitch and it requires more force, but fewer turns, to get it in. They haven't proven, and probably can't prove, that pullout is better. It is the same concept with Xia screws (which were proven to have less pullout strength than a comparable sized conical or cylindrical screw even though ins. torque was higher).

The CoCr is also a feel thing but provides no benefit (other than imaging) over SS, in fact it is more brittle than SS and may be inferior in performance.

Not only did you drink the Kool-Aid, it left a permanent red stain on your lip.

Who's tearing down Spine, we're reporting what was heard on the Street. Dude, it's a blog don't get your knickers too tight. I thought you MDT boyz were tougher than that. Oops, I forgot you've become a company of entitlement.

Reading your post has diminished my already dwindling IQ to near challenged levels.MDT is in no way comparing CoCr to Stainless Steel, rather to CP Ti and Ti Alloy. So your multiple paragraphs of rambling have no merit.

And you would submit to me that a PLASTIC rod has a similar stiffness to a TI or CP TI rod? Really?? That actually does not even deserve a response, if you knew what you were talking about you would not have wasted our eye movements by typing that.Oh and your mom has a white stain on her lip.

MM, there is not a PEEK LAB in Memphis this weekend or any other weekend... was this a joke or do you get your intel from truckstop bathroom stalls whilst tapping your foot on the floor?

7:50Medtronic reps are, in fact, claiming that the Solera system with CoCr offers the same stiffness of construct as the Legacy 5.5 SS. I have had a surgeon report that to me, and of course he bought it, until I straightened him out.

As far as the PEEK rod and Solera Ti rod being of similar stiffness, the PEEK rod is approximately 6.35x7mm while the Solera rod is 4.75mm. So yes, I am suggesting that the softest metal rods in 4.75 are probably very close to the rigidity of a much larger PEEK rod. Its not as simple as "plastic versus metal". But in a cantilever load (look it up), these two dissimilar materials in dissimilar dimensions offer similar "load sharing" (to use a term from your brochure).

Based on your comments about my mother, I am certain you have a firm grasp of metallurgy and biomechanics. I am certain you have a firm grasp on other things as well.

If Medtronic reps are comparing 4.75 CoCr to SS then they are sorely mistaken and deserve to have their business snatched by you.

You can gargle off numbers and stiffness to me all day long, but the proof is in the pudding my friend. If you take 2 Solera screws with a 40mm 4.75 CoCr rod attached and torqued and you do the same with a Peek rod and two screws torqued and you do the old squeeze test, you will find that the PEEK construct is MUCH less rigid than the CoCr rod. I would wager that you could barely get the CoCr construct to flex, where as the PEEK construct would flex fairly easily... even under the power of your limp wrist.

Is a YouTube video in order to prove this or are you going to tell me they both will have the exact same characteristics?

Are there any post operative studies for a patients maximum weight getting a 4.75 CoCr or 6.35 PEEK Rod implanted? Do you have to maintain a diet, because this fat kid loves cake! PS- It's a blog, not Sunday church. TSB keep the topics coming.

Bogus Information? What do you think this is OTW, Orthoworld, or Ortho Spine News reporting on daily Press Clippings? Besides, no one is charging you to read press clippings that can be accessed on Google or Yahoo Finance. Remember, it's a blog, it's what's been heard on the Street. If this is the worst that you can accuse TSB of, let me fall on the proverbial sword. Mea Culpa, Mea Culpa. Even the Wall Street Journal isn't perfect. It's Friday, the sun is shining and I'm healthy and happy and that's all that matters.

My comparison is to PEEK and Ti rods and if you don't think a 4.75 Ti rod won't flex easily you are mistaken. A 5.5 Ti rod flexes noticeably in the test you describe and rod stiffness goes down exponentially (look it up) as diameter decreases. (another fact you are undoubtedly aware of)

TSB, I have called you all sorts of things in posts on your blog, some in jest, some not, my most common accusation has been that you are a socialist. This time, though, I must defend you, as some of these wankers are all over you for the inaccurate info on the lab. GET OVER IT guys! I think you put it well MM in your last post. Actually, maybe you should intentionally make stuff up, just to get a rise out of the guys who wear their jockeys too tight in the first place...I find their tirades sort of entertaining.

As for the topic: To those of you trying to profess the benefits or tout the characteristics of PEEK rods; please, please, please don't insult us all with your nonsense. You tools that quote stats on 4.5mm or 5.5mm CoCr rods or Ti rods, get a life. If you think that knowledge (for lack of a better term) differentiates you from the rest, you are nuts.

This business is about service, problem solving, and relationships, and when it comes to products it is about ease of use, and instrumentation (which go hand in hand.) I defy anyone to show any proof that Screw A with Rod A leads to better outcomes than Screw B with Rod B.

I do believe that Technique A versus Technique B can and does lead to better outcomes, or shorter stays/recovery times, and there are studies that prove this.

The most important element of this whole process, is something that we the reps have no (or very minimal) control over: surgeon skill and perspective. We can help them to become proficient with our instruments, and products, but if they have lousy hands, they have lousy hands. If they perform a sloppy discectomy, because their mentor in fellowship trained them that way, you can only subtly address it. Your best bet is to get them with better surgeons at corporate training events, and hope something rubs off.

There are surgeons that just have IT, and others who will never have IT...just like in sales. That is ultimately what makes your products perform well or not. Get over your features or benefits, unless you have something that is truly unique. While you need to know your specs, your constant purging of product data is tiresome.

I pray for huge consolidation in this industry, so that all of the dead wood can be trimmed out. There are so many amateurs and idiots around now that I am sometimes embarrassed by association.

No matter which strip club you go to in Memphis, ask for the Semmes Murphey Special" sponsored by MDT. That gracious act is performed on the main stage. If you want the dark room special, just ask for the "MERI", ALSO sponsored by our very giving friends @ MDT

I have a question for those in the know regarding medical device sales and representation. Will a facility (hospital) allow a person with a felony drug conviction into the premises to sell and / or cover a medical device product / case? Does this create a situation for additional liability?

Wait till Tornier comes up with Pyrocarbon rods...another twist in the tale...It has elasticity similar to bone, as claimed by PEEK...Regardless, I wonder how proud the owners of memphis strip clubs are today- being discussed by intellectuals in spine industry......

I've made a pretty good living in this business differentiating myself from you "tools" with knowledge. And while I agree with you that this business, and most, are based on service, problem solving and relationships, I personally think knowledge is key to all three of those things. As far as products, you are right, again that Screw A and B are virtually all the same (in technique and outcome). What knowledge can do is discuss the various characteristics of each nuance relative to specific pathology. There is clearly a difference in a 6.35 SS rod and a 4.75 CP Ti rod and that has relevance in various applications. The post above seems to be a vomit of facts, but it is relevant to the discussion of PEEK in the marketplace and I, personally, would like to see the data that resolves the dispute.

Does anyone remember the days when PEEK implants were approved as cement restrictors and had that black label on the box? Invibio struck gold the day that Medtronic Sofamor Danek decided to figure out a way around the PLIF bone shortage and chose almight PEEK as their vehicle.

The industry hasn't really evolved in 15 years with the exception of some gimmick approaches that do have merit in some cases along with refined instrumentation.

The real bottom line of spine surgery is this: It comes down to patient selection. Sadly, there are many surgeons out there, regardless of their technical prowess / hands, are terrible at the most important part of surgery.......... The decision of who they take to the OR.

What's the big deal about CoCr rods? These have been around a while...but PEEK rods? That's becoming a stretch. I've had PEEK cages break in L5S1, why the hell would I trust putting in a PEEK rod that is engineered with simple geometry with less structural tolerance than a cage? Think the glubus guys have peek rods too just too start the bashing.

Fact of the matter is that nobody can threaten MSD. and if someone gets even close to that, MSD will acquire them.As much as everyone hates them, they are to the spine industry what US is to the world.cheers...

The load sharing argument has too many holes in it. Since this shifts more load on the anterior column we will see more anterior degeneration. The point of a fusion is to fuse bone, not rely on the construct to maintain the decompression. This isn't a motion preservation device, can't have it both ways. And please don't give me the Wolf's law spin regarding the load sharing bull shit. Numbers can be manipulated and marketing can do wonders. Common sense says this is not an appropriate replacement. Believe this, and I'm sure you believed Ricky Martin was straight, too. Good luck.

Mr/ mrs anonymous who stated ' Anonymous said...I am a former Medtronic rep and PEEK rods have been out close to 4 years it seems. I remember the regional compensation plan meeting where they put an incentive on PEEK rods, Agile dynamic stabilization and Prestige cervical disc. Prestige wasn't even FDA cleared yet and there wasn't a single study on Agile or PEEK rods to even suggest that they were as good as, much less better than SS or Ti. We didn't even have to ask why they were putting the focus on these products, the theme of that meeting and the NSM was "Differentiation", no one else had those products. They even went as far as saying that PEEK rods had a low barrier to entry into the market so we needed to act fast because everyone else was going to have one within 2 years. It didn't turn out that way for a few reasons. We all know what happened with Agile, complete fail, and Prestige hasn't done much either.

We did ask why they designed the PEEK rod so that it wouldn't fit into any of our existing screws and their response was that they felt the oval shape improved biomechanics. Yet, they didn't know what biomechanical goal they were shooting for since this type product had never been studied. We all knew the real reason was that it created a new catalog number for the screw that would now be classified as "new technology" and the price was set accordingly.

It was a bit of a defining moment for the company and for me. I have since left and I feel they also have left their once great path. Does anybody remember the term "integrity pricing"? This was their way to charge more because they bore the burden of doing "all" of the R and D in the industry and everyone else just copied them. It was bull then and even more so these days. The only product they announced at NASS was a freaking curette for the Kyphon system. I guess all the R and D money goes to CRM, but not to spine.

They ain't who they used to be, no leaders, too many lawyers, too many consultants and bogus IP deals and a sense of entitlement to the business. Someone above asked why they are still the market leader? It's because they had such a huge lead and they grew that lead for over a decade. But the lead is dwindling, and it will take a while, but they will blow it eventually unless they have a major change of course.January 20, 2011 7:16 PM '

You Hit the nail straight on the head. I put in over a decade and lived through this.God bless your honesty and clarity.

As per TSB's previous comment, we only report what's been heard on the Street. In hindsight, we should have placed a question mark after the title of the post. This post has raised a great discourse about the bio-mechanical efficacy of PEEK Rods in comparison to CoCr and Ti-Alloyed Rods. Unfortunately, bloggers failed to elaborate as to whether they thought a PEEK Screw was a viable consideration. The collective "we" have heard of companies toying with ceramic coated screws, with expandable screws, etc, so who's to say that someone is not attempting to develop a PEEK Screw?

At this juncture, many legacy companies like Medtronic, are focused more on marketing than actual innovation. Like many of you know, if it doesn't change the outcomes, what we're doing is coming up with systems that focus more on technique and approaches rather than outcomes. We value your critique and appreciate your honesty. Have a great weekend.

Never say never!There is possibility of making PEEK screws. There are enormous challenges though, in terms of manufacturing regulatory and biomechanics. Ceramic coated screws, ready to be used in spine are still far away. But hey, if u get higher premium, why not make them.

MDT is lost and years behind in their pipeline. All their eggs were in motion (Prestige, Agile, Maverick, etc.) PEEK screws were bantered about for awhile but they are too concerned with their dwindling market share too invest properly. Acquisition is the name of the game and fending off the gooberment to show how squeaky clean they are. Just keep hammering them on price and they will fall to their knees as quick as your teenage daughter back stage at a Jonas Brothers concert.

Its exactly this mentality that will feed the cannibalism and tunnel vision of the industry. Competitors are not marketing their products on its merits AND value, rather value alone. At that point everyone loses because we are no longer innovating and only trying to produce the next cheapest product to snag market share. TSB is so focused on products that improve outcomes and revolutionize, but sadly with this mentality in the market those days are dwindling.

As for PEEK screws, I just don't think there is a market for them and I think its a stretch (like the resorbable ACDF place).

On another note, what would be the advantage of Ceramic coated screws? I know MDT has HA coated screws, similar philosophy?

Isn't that how a free market economy works? When there are multiple, similar products to choose from, and no real utilitarian advantage to any of them, the only factor the customer has to consider is price. It is how it SHOULD work...Simple supply and demand economics. As I said before, I hope the industry consolidates so the dead wood is removed.

Face it fellas, prices will fall. There is no way to avoid it. I don't like it, as I obviously want to maximize my income, but it is the natural cycle of free markets. We have been lucky to ride this horse as long as we have. Frankly, prices should have fallen years ago. The upside is, that eventually market pressures will force everyone in the chain (manufacturers, hospitals, doctors,insurance companies) to take their respective haircuts. It doesn't happen overnight as so many wish, but it will eventually happen. The end result will be that our healthcare costs will go down, unless the government tampers too much, which will likely happen, and that will screw everything up, and artificially inflate the market.

My suggestion to anyone trying to build a territory without a nice book of business is, start a POD with a few docs to gain the relationships (ride that horse as long as you can, because it will come to an end,) find a legitimate new technology and weather the regulatory/adoption period, or find a new industry or some other growth segment of medical devices.

Don't work for MSD, been there, done that. Great learning experience. Since have had lots of experience with just about everything dynamic or load sharing. As far as no information, sorry, it's out there and the results are pretty darn good. Are there problems? You bet. PEEK rods, especially the MSD system.

The rod is oval, you can't bend or shape it so screw placement is critical. Why do a lab? The concepts behind plates and bolts have been forgotten. You have to plan ahead, know where the screws need to go to accommodate the rod. If you want the system to work, best know how to do that. Does it load share? In theory it does, and in cadavers is does, but in-vivo, not body really knows since live patients don't deal well with sensors in their spines.

They do break, especially if put in wrong. And rods loosen from cold flow; hence the promotion of BMP - fuse it fast before $%&* happens.

Don't discount this technology. PEEK does have pretty interesting characteristics and somebody is going to figure out how to make it or something similar work. Old school thinking that all can be healed with steel is going to be challenged. Why? Too much success (not great but approaching metal) and very few alternatives. Companies need a differentiator; just too much financial opportunity.

@ 4:52 - most new product development projects in this business serve this purpose. All have basically one or more of three functions:

1. To develop a new product that benefits patients or medical treatment in some way. It may only be a slightly better version of your own current product, or the same as a competitors's, and intended to either maintain or increase market share. Contrary to many people's opinions, there's nothing wrong with that.

2. To forge or foster a productive collaborative relationship with one or more prominent or high-volume surgeons, with the hope that your business with them will continue or increase. As tasteless as this may sound to some, when you break it down this is a normal and common practice in any industry and a productive part of a capitalistic marketplace, as long as it's not resting on a quid pro quo foundation. (Unfortunately, some projects from some companies have this as their primary foundation, and do rest on an inherent quid pro quo basis.)

3. To add new products and part numbers that surgeons are interested in using and can command premiums and/or fall outside of existing pricing contracts. Again, nothing wrong with this as it's up to the surgeon's and hospitals to demand that the pricing match the previous agreements, or at least fall in line, or they should just keep using the "old" stuff.

Soft goods solutions & nucleus replacement will become the next evolution in spine. Fusion devices & TDRs will become things of the past.

The abilty to address spinal pathologies in thoughtful ways which will help slow down the degenerative cascade is where the market will head as healthcare & reimbursement issues will force it in that direction. Patients are now living longer than ever before,, Why not look to solve the age old challnege of managing disc degenration while maintaining facet integrity??

Solutions to this are on the horizon which will clearly address these issues and lead to an overall reduction in spinal fusion surgery moving forward.

Those not at the forefornt of this move will be left in the dust.

Thought leaders in spine, please step forward and leave all of the other monkeys behind.

Your comments sound as if you attribute cost of healthcare solely to spinal implant pricing? Cutting dead wood will force healthcare costs down? Were you born last night? It will not and spine is the proverbial flea on the ass of the monster that is healthcare.

And to ALL of you price choppers out there, the quicker you drop your pricing panties the faster the legacy companies will do the same with their commodity lines and your jobs will be gone along with the 510k companies you work for. Anyone remember the total joint market about a decade ago? Tons of companies in the game pushing price lower and lower.... Zimmer, J&J and Stryker commoditized their core lines and put most of the other companies out of business. Did health care costs go down? No, in fact they have steadily risen and those big 3 joint companies are still charging a premium for "non-commodity" joints (ceramics, coated, gender specific, etc). So I think the pricing spiral is inevitable, but I think that those of you working for the me-to companies that are driving it in that direction will soon be ringing a bell at christmas time outside the local walmart.

As far as PEEK screws, I personally think its right up there with resorbable plates...worthless.

Also, what is the benefit of ceramic coated screws? Similar benefit to HA coated screws?

12:52Another dynamic you are missing when it comes to price cutting is that the Medtronic reps making 6.25% get hurt worse when prices come down than reps making a more standard rate. Even if Medtronic can weather the pricing storm, will their reps hang on for such paltry commissions or will they broker their business with another company paying higher commission to keep their income stable, or even higher. Medtronic is the 800 pound donkey for sure, but they still are at the mercy of their reps for the bread and butter business. And for you to call any of the smaller companies "me too" is a bit hypocritical. Medtronic didn't invent the pedicle screw or the cervical plate. Their innovation is moving at a snails pace right now and a tiny percent of their gross sales come from proprietary technology (other than Infuse, which they didn't develop).

I think MM has a real hard on for Medtronic. He must be a former disgruntled employee. He seems to write about them alot and knows many obscure landmarks in the Memphis area.

It's funny that no one talks about all of the other companies in the industry. I guess Medtronic is the only one with consulting agreements. I don't hear anyone talk about all of the nice trips to the San Diego area. Good fishing trips, golf outings and much classier strip clubs than in Memphis. By the way PP has been closed for more than 4 years now. Globus is another great company that has built their revenue stream through hard work, great innovative products, and a knowledgable salesforce. K2M seems to be really picking up steam with their creative consulting agreeements as well. Honorable mention for ethical companies go to Sea Spine, Stryker, Spinal Solutions, Lanx, Alphatec, Theken, Pioneer, Blackstone, and another hundred or so companies out there now. It's just funny that you continually focus on the largest company out there. They must be doing something right to maintain market share with their customers.

12:18 I want access to what your smoking. Soft Goods, please. Necleous replacement is coming, no doubt, but when and will anyone committ to the serious funding to do an IDE and then later, get third party payers to pay for it. An IDE is at minimum a $45MM study and 5-6 year project. That's a long run for what could be a very short slide.

Should patients wait six years to have availability to a possible solution? Folks aren't going to wait. If they need something done, it won't wait six years.

Many of my peers were on a mission to kill dynamic stabilization and fusion several years ago. It didn't make a lot of sense to many of us and I was not afraid to lead a charge against the dynamic developers. Since then, having seen what a benefit they can be (if used appropriately by a competitent surgeon). No way would I have a fusion on myself without serious consideration to some form of dynamic stabilization. PEEK rods, the TTL rod or similar, Dynesys have a place, a significant place, in the continuem of care until something better comes along.

I'm an old guy, been in the business from multiple sides for a long time. In this informational age, I am continuously amazed at the short sided views of so many. Go read something - actually go a make an investment in your profession. You will be amazed at how it will improve your ability to actually discuss and sell something.

I'm with 8:34 on nucleus replacment. Its a very difficult thing to justify for an investment because discectomy (without replacement) is likely the best spinal operation going. The benefit is likely to be reherniation rate or disc collapse, both of which would take years to demonstrate a clinical benefit.

PEEK rods (much less screws) are a red herring. They will increase the cost of care and aren't likely to offer any benefit, with the exception of making a broken rod less obvious. Why would they offer a significant advancement on any of the other lackluster dynamic stabilization devices? Does PEEK have some magical stiffness value? I don't buy it.

It seems unlikely that real innovation in the treatment of spine is going to come from any of the metal companies. One of the industry stayings is that if you have a hammer everything looks like a nail. Usually hear it with respect to surgeons. They know how to fuse- so everyone gets a fusion. Its more applicable to these metal companies. Their entire raison d'etre is hardware so that's the box they operate in. To change that requires a big retooling of the company, management to engineer, or acquisition. Hardware will continue to get crunched on price, and it should. Legacy companies will continue to refine their systems and make marginal improvements. That may be considered innovation but its unlikely that any such improvments will be significant enough to impact pricing. Clearly PEEK rods were a deparate attempt to manufacture differentiation and impact price.

Spine is a complex problem with many 'pain generators.' Spine is not a hip or a knee. Discectomy works well because it addresses a single problem. Single level fusion on an isolated disc works pretty well even if it doesn't happen that often. What type of outcome can really be expected when you have a fully degenerated spine? Fusion may be the best solution for those patients. PEEK isn't necessary for that.

8:34 AM.Sir,you are right in pointing out the benefits of dynamic stabilization. However, It will take a lot more time to reach the stage where these devices are widely used. Just to put things in perspective, one of the most talked about and convincing technologies developed by Applied Spine failed to make it through the IDE. Part of the reason is FDA who directed AST to wait for a year before enrolling any new patients. FDA is becoming very tough to work with. Good they are cooling down after Obama's directive last week.

Anyone see this story about the government creating a federal research center to develop new drugs where industry has 'failed?'

http://www.nytimes.com/2011/01/23/health/policy/23drug.html?src=me

My initial reaction to this is amazement at the degree of arrogance that the government thinks it can spend a 'measly' billion dollars to make up for the short comings of the greedy pharma companies. Would this not discourage traditional investment in new drugs? Why not loosen the regulatory burden to achieve the same end?

This got me thinking what might be next. Could the government start forming its own device companies to knock off 'expensive' products with 'weak' patent protection (everyone else is doing it) and sell exclusively to CMS? A government run, not-for-profit spine company would play havoc on pricing. I know I'm bordering on conspiracy theory!

I always wondered why reps would work for MDT at 6.25% when they could earn 4-5X that consigning from one of the independent companies.

Other than Infuse (becoming more limited due to high price and labelling limitations) and the O-Arm (rarely used), an alternative to every one of MDT's products could be provided by the independent companies.

I'm sure that MDT's name and corporate marketing machine bring business, but their reps pay a very steep a price for it.

You're an old guy, huh? Last time I checked Dinosaurs did die off when they no longer could adapt to their surroundings,, perhaps you're in for a similar fate?

I didn't say that nucleus replacement would be here next week,, but it will be here. My point is that there are way, WAY too many fusions being performed these days; 1/2 or more of which fail in the end. Not great odds with all of the scrutiny on spine these days.

Let me ask you, since you seem to have all of the answers,, What is the most common reason for a failed fusion? Let me help you,, the answer is an incomplete decompression of the foramen.

That said,,, next question: How do you provide a complete decompression which addresses central, lateral recess & foraminal stenosis all at once while providing NO disruption to the facet joint?

You create a device that can do it from the inside out, leaving the facet joint & capsule fully intact. Stability is therefore maintained & there is really no need to fuse,, unless of course you're talking axial back pain which is a seperate discussion.

The takeaway is that solutions like these are here and others are coming down the pike too,, so keep peddeling metal, I'll line up for one of these newer opportunities.

A full, un-instrumented decompression which maintains the facet joint, maintains stability and also offers the ability to deliver a nucleus replacement type substance to a degenerative disc,,, sounds like a winner to me.

So while you may think I'm out of my mind,, I guess you were the ONE person who told Dr. Michelson that pedicle screws & interbody devices were a BAD idea in the 90's??

As they say, Pioneers are the ones w/ the most arrows in their backs; I'll be happy to have you shoot an arrow at me.

As a casual observer you sound like a total idiot, must be a Medtronic gnome and don't like being singled out for real innovation, PEEK rods. By the way, Peek rods are going in the same direction that Peek IM Nails are going, NOWHERE. Go back to Memphis and see if you can sign some more consultants and then hide behind AdvaMed, LOL.

You cannot perform a complete decompression of the lateral recess or foramen while leaving a facet joint fully intact. A pathologic facet joint is most often the cause of foraminal stenosis. Don't try to make other people look ignorant because they don't always agree with the mission of the company you represent. Even your argument that most failed fusions are the result of incomplete foraminal decompression is suspect and biased toward your product (whatever it is). You sound like the Nuvasive guys that say direct lateral can address ALL pathologies of the spine (unless you include L5-S1 and cervical, the most commonly pathologic segments). I'm not saying that facet replacement won't have a place when the right product and technique is developed, but don't narrow your view simply to make your product more appealing, it makes you seem brainwashed.

1/21 7:49Do you really think that Depuy piece is educational. It was a simple bench study trying to show the load transfer to the anterior column with PEEK vs Ti. The conclusion was that "PEEK rods may support the fusion process by increasing loads on the anterior column bone graft while reducing loads on the bone screw interface". They may also do nothing and they may also cost more. It is a bit of an issue that surgeons are using them without anterior column support and they are also adding screws and "topping off" a fused level with another level that is simply instrumented. Better hope the DOJ prosecutors that busted Kyphon don't get wind of that billing scam.

There is a lot wrong with that bench study that was clearly manipulated to convey the point the marketing team was after. I ain't buying what your selling.

5:36, you are obviously a complete newbie and so way out of your league. Off the top of my head I will tell you that Cloward was putting in lumbar interbody grafts in the 40's, and Roy-Camille was putting in pedicle screws in the 60's. Any attribution to Michelson of anything other than making iterative changes to existing technologies and techniques and patenting them, is complete nonsense. He is not a pioneer, in any sense of the word.

I see a place for PEEK rods, combined with a TLIFF cage, but never alone, cause that defeats the purpose. Most surgeons will not go for it, cause there are allot more on offer from other compeditor companies... As for the strip bar comments, this is such and old, borring topic, that floods this blog daily... Comment on the spine topic, and enlighten us with your spine knowledge instead of beating the same old borring "strip bar" drum. If you cannot add to the topic, shut up.

10:48 here. Your argument is full of logical fallacy. Strange that you talk about the small impact spine will have on the overall picture, then you cite joints as proof that my comments are wrong. Actually your argument proves mine. Prices in joints were driven down by competition and market pressure, now it is happening in spine, once this happens in enough segments of healthcare, and pricing reaches supply/demand equilibrium, other areas (hopsitals, doctors, insurers) will have to address their inflated margins/cost contribution to the overall industry. I clearly said it would not happen overnight, or even quickly. You, as well as the rest of the spoiled brats that make up the bulk of this industry, want your oompa loompa, and you want it now! You must have been born yesterday, idiot. It is in response to babies like you, that the government is expected to make all of our problems go away. You are short sighted, and you are the problem.

Dynesys? Really. Why does a stable construct require 'dynamic' stabilization? If I have radicular symptoms due to foraminal stenosis I think I would go for a foraminitomy and leave the hardware on the back table.

@ 7:28. Read what your customers read: Spine, The Spine Journal, JSDT, ESJ. Yes, many docs don't, and with them you can discuss the usual: their practice, sports, pretty nurses, hunting, etc. But if you want to take your game to the next level with the academically minded, knowing and integrating the science into doing your job will make you stand out. If your company offers you access to these journals, take advantage of it.

-I wonder if the farrier thought Steffee was on a consulting deal. -I'm sure the animal was able to load transfer more efficiently and won the triple crown that year. -I bet they were disappointing since they don't make that nice "ping" when you get a ringer.

4:44, you must have worked with Art at arm's length, because you got it completely wrong. His thought was that a 70% carbon fiber reinforced PEKKEK horseshoe might be beneficial for race horses because of the reduction in weight. In itself another brilliant idea by the grand old man, which never came to reality. But look at cars these days......

5:36I'm late checking in... but you are a complete moron. rotflmao!Decompression of the foramen has nothing to do with fusion success! Jesus, seriously?!Perhaps, they will still have pain, sure... but, zero to do with fusion, dumbass!

Fusion failure is usually from micromotion, undersized graft and/or poor placement of graft!

You seriously must be a laughing stock in your marketplace. What other grand advice to you have for us? You should start a blog so I can get a good belly laugh everyday.

All of this blah-blah may someday be irrelevant. Which may not be a bad thing considering the MDT PEEK construct with it's "special" screws cost 2-3 times more than the traditional pedicle screw systems out there. That won't fly with healthcare reform on the horizon. Dynamic stabilization may be on the bubble with the FDA is putting it under a microscope.

Here is a link to the FDA letter to Alphatec, but many other companies are included in the 522. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm239848.htm

Alphatec was issued a warning letter for deficiencies in its 522 postmarket surveillance study protocol for the Zodiac DynaMo Semi-Rigid Spinal System, the ISOBAR Semi-Rigid Spinal System, and the ISOBAR Semi-Rigid Dual Dampener. In October 2009 the FDA ordered manufacturers of 16 dynamic stabilization systems to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries. The studies were to address the following: :1) the fusion rate for dynamic stabilization systems compared to traditional stabilization systems; 2) the incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems; 3) the type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and4) the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure. Other manufacturers and devices included under this 522 include: Zimmer's Dynesys, Globus Medical's Transition, Synthes' N-Hance, Paradigm Spine's DSS, BioSpine's BioFlex, Medtronic and DePuy Spine's PEEK rod systems. No other warning letters have been posted related to this postmarket surveillance study.

All of you spine reps are fucking tools that think you are surgeons. You are good at regurgitating the shit you learn in training, kissing surgeons asses and claiming you differentiate yourself with knowledge.

What should you do when 2 hospitals catch a competitor using instruments from your trays? In one hospital, he even tells them that the instruments are his. Both hospitals contact you to report it immediately.

OK 4:16. Ease up there sport. You're just another OR Tech starting to sound like us jealous spine surgeons who's volume is too low to be allowed by our counterparts to get into their Surgeon Owned Distributorship.

I am just one devestated surgery patient that is not through my recovery period from complete spinal reconstruction and waitin on my doctor's to find a spot in O.R. for me as I speak because on of the Globus Cobalt Chrome Rods 500mm that was installed in my back snapped completely into. I am very depressed at this moment. My first surgery was a one year recovery & do imagine this will be the same!